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The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer.

Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. The ISE module measures sodium, potassium and chloride using ion selective electrode technology.

Here's an analysis of the Poly-Chem 90 ISE Module's acceptance criteria and the study proving it meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Poly-Chem 90 ISE Module appear to be established by demonstrating substantial equivalence to the predicate device (Randox RX Daytona ISE Module) across various performance characteristics. While explicit numerical "acceptance criteria" are not stated as pass/fail thresholds independent of the predicate, the comparison implicitly sets the predicate's performance as the benchmark.

2. Sample Sizes Used for the Test Set and Data Provenance

The document provides sample sizes for the method comparison studies (where the device is compared to the predicate), which can be considered part of the test set:

• Sodium (Na): 63 samples
• Potassium (K): 74 samples
• Chloride (Cl): 74 samples

The precision, linearity, and sensitivity tests also involved samples, but the exact number of unique patient samples isn't specified in detail beyond "Samples from [range] mmol/L" for precision.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions the measurement of levels in "human serum."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" would typically refer to the reference method (the predicate device in this case, or a gold standard method) rather than expert interpretation of images or clinical data. There is no mention of human experts being involved in establishing the "ground truth" for the performance characteristics of this chemical analyzer.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established by chemical measurement, not through expert review and adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not applicable to this type of device (in vitro diagnostic for chemical analysis). This study design is typically used for imaging diagnostics where human readers interpret results, often with and without AI assistance.

6. Standalone Performance

Yes, a standalone performance evaluation was done. The precision, linearity, and sensitivity studies presented in the "Summary of performance testing" section (pages 3-4) directly demonstrate the performance of the Poly-Chem 90 ISE Module itself, without comparison to the predicate. The method comparison studies (page 4) also provide the device's measurements, which are then compared to the predicate, implicitly showing its standalone output.

7. Type of Ground Truth Used

The "ground truth" for evaluating this device's performance appears to be primarily:

• Reference measurements/Method comparison: The predicate device (Randox RX Daytona ISE Module) serves as the comparator for method comparison studies, implying that its measurements are considered the "truth" for this comparison.
• Established analytical methods: For precision, linearity, and sensitivity, the ground truth is based on the inherent principles of analytical chemistry and expected performance characteristics for such assays. For example, linearity is assessed against a theoretical linear response, and precision against statistical variability.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its sample size. This device is an in vitro diagnostic analyzer, not an AI/ML algorithm that typically undergoes a distinct training phase on a dataset. Its performance is characterized through analytical validation studies (precision, linearity, etc.), not a machine learning training process.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's operational parameters and calibration are established through standard analytical chemistry principles and calibration procedures (e.g., using Medica Calibrator A and B, as mentioned) during its manufacturing and setup, not through a data-driven training process.

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The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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This document is a 510(k) clearance letter for an in vitro diagnostic device, the Poly-Chem 90 Albumin, BUN, Calcium, Carbon Dioxide, and Creatinine tests. It is not a study report or clinical trial document. Therefore, it does not contain the specific information requested about acceptance criteria, device performance, study design, or ground truth establishment.

A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not typically on a new clinical study with acceptance criteria and performance metrics described in detail within the clearance letter itself. The types of studies referenced in your request (e.g., sample size for test set, expert involvement, MRMC studies, standalone performance) are more common for novel or higher-risk devices that require a PMA (Premarket Approval) or for performance studies conducted by the manufacturer that are submitted as part of the 510(k) but not fully detailed in the FDA's clearance summary.

Therefore, I cannot provide the requested information from the provided text. The document primarily confirms that the FDA has reviewed the manufacturer's submission and found the device substantially equivalent to existing devices, allowing it to be marketed.

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Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.

This document describes the performance testing of the Poly-Chem 90 Total Bilirubin device, a reagent/test system for quantitative in vitro measurement of total bilirubin in human serum.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria: The document implies that the acceptance criteria are met by demonstrating "substantial equivalence" to the predicate device (Poly-Chem Total Bilirubin, K973995). Therefore, the reported device performance is compared to the predicate's performance to establish this equivalence. While specific numerical acceptance criteria are not explicitly listed as pass/fail thresholds, the statistical results (e.g., correlation coefficient, confidence intervals for slope and intercept) are used to support the claim of substantial equivalence.

2. Sample Sizes used for the test set and the data provenance:

• Precision: No explicit sample size is given for the precision runs beyond "Sample 1", "Sample 2", "Sample 3" across two instruments. Each "sample" likely represents multiple replicates over several days to determine within-run and between-run variability. The values presented are means, SDs, and CVs, implying multiple measurements. The origin is not specified, but it's likely from internal lab testing given the nature of a 510(k) submission for a diagnostic reagent.
• Linearity, Sensitivity, Interference: No specific sample sizes are given, but these are typically determined through laboratory experiments using controlled samples.
• Method Comparison: 82 samples were used for comparison with the predicate device.
  • Data Provenance: Not explicitly stated, but given it's a 510(k) submission for an in vitro diagnostic, this data would be from controlled laboratory studies, likely using human serum samples. The country of origin is not specified, but the manufacturer is based in the United Kingdom. It is a prospective study as it involves new testing of the Poly-Chem 90 and comparison to an existing device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to this type of device and study. This is an in vitro diagnostic (IVD) reagent for measuring a quantitative analyte (Total Bilirubin). The "ground truth" for method comparison and performance characteristics is established by a reference method or the predicate device itself, not by expert interpretation of images or clinical cases.

4. Adjudication method for the test set:

Not applicable. As an IVD for quantitative measurement, there is no need for expert adjudication. The comparison is against established laboratory methods or a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a chemical reagent and instrument system, not an AI-assisted diagnostic imaging tool that involves human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, in essence. This device inherently operates in a "standalone" manner. The Poly-Chem 90 analyzer, using the Poly-Chem 90 Total Bilirubin reagent, provides a quantitative measurement directly. There isn't a "human-in-the-loop" interpretation step in the same way as with an imaging AI system. The performance characteristics (precision, linearity, sensitivity, comparison to predicate) are all measures of the algorithm/reagent's accuracy and reliability in providing the numerical result.

7. The type of ground truth used:

• Method Comparison: The "ground truth" for the method comparison study was established by the predicate device, Poly-Chem Total Bilirubin (K973995). The results from the new device (Poly-Chem 90) were compared to the results obtained from the predicate device on the same samples.
• Other performance metrics (Precision, Linearity, Sensitivity, Interference): These are inherent performance characteristics determined against established laboratory practices and analytical standards. For example, linearity is assessed by testing known concentrations, and sensitivity by calculating limits of detection/quantitation based on statistical methods from repeated measurements of low-concentration samples.

8. The sample size for the training set:

Not applicable. This device is a chemical reagent-based diagnostic system, not an AI/machine learning model that requires a "training set." The performance is characterized through traditional analytical validation methods.

9. How the ground truth for the training set was established:

Not applicable. As stated above, there is no "training set" for this type of device.

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The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis.

The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.

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This document is a 510(k) premarket notification from the FDA for an in vitro diagnostic device (IVD) called "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests."

It is important to note that a 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance data, but it does not usually include the level of detail regarding acceptance criteria, study design, and ground truth establishment that would be found in a full efficacy study for a novel device or a clinical trial for an AI/ML-based device.

The document does not contain the detailed study information required to fully answer the request, particularly regarding acceptance criteria and the specifics of a study proving the device meets them in the context of an AI/ML device. The device described here is a chemical assay kit, not an AI/ML-based diagnostic.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer based on the available information, with clear indications of what is not present:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The 510(k) summary (which is not provided here, only the decision letter and indications for use) would typically contain performance characteristics like precision, accuracy, linearity, and interference studies compared to a predicate device. Acceptance criteria for these metrics would have been established by the manufacturer and accepted by the FDA for the substantial equivalence determination.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. For an IVD, the sample size would typically refer to the number of patient samples tested. The provenance and study type are also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. Ground truth for chemical assays like cholesterol levels is established through reference methods (e.g., gas chromatography-mass spectrometry, ultracentrifugation) or comparison to well-established, previously validated commercial assays, not typically by expert adjudication of images or clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. Adjudication methods like 2+1 are used for interpreting qualitative or subjective data, often in imaging or pathology.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. MRMC studies are used for evaluating diagnostic performance of systems involving human interpretation, often with AI assistance, which is not the case here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. This concept applies to AI/ML algorithms, not to a chemical assay. The Poly-Chem 90 operates as a standalone analyzer for measuring these analytes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of chemical IVD, the ground truth would typically be established through:

• Reference methods: Highly accurate and precise laboratory methods (e.g., GC-MS for cholesterol, ultracentrifugation for lipoproteins) used to assign true values to samples.
• Comparison to a legally marketed predicate device: The submitted 510(k) is based on demonstrating substantial equivalence to existing devices. Therefore, the predicate device's performance would serve as a de facto "ground truth" for comparison, provided the predicate itself was rigorously validated.

The specific ground truth method used is not detailed in this document.

8. The sample size for the training set

This information is not applicable/relevant as this is not an AI/ML device with a training set in the typical sense. For a chemical IVD, "training" might refer to calibration procedures, which involve a very small set of known standards. This information is not present in the document.

9. How the ground truth for the training set was established

This information is not applicable/relevant for the reasons stated above (not an AI/ML device). If considering "training" as calibration, the "ground truth" for calibration samples would be established by preparing precise concentrations of the analyte using primary reference materials. This information is not present in the document.

Summary of what the document DOES tell us:

The document is an FDA 510(k) clearance letter for the "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests." This device is an in vitro diagnostic procedure intended to quantitatively measure these lipids in human serum on the Poly-Chem 90 analyzer.

• Indications for Use: The document clearly outlines the specific medical conditions for which each test's results are used (e.g., diagnosis and treatment of lipid disorders, assessment of cardiovascular disease risk).
• Regulatory Classification: Class I, falling under specific regulations for lipoprotein test systems.
• Device Type: This is a chemical assay kit designed to measure specific biomolecules in a laboratory setting, not an AI/ML-based diagnostic.

Therefore, the detailed questions about AI-specific study methodologies (MRMC, standalone AI performance, expert adjudication, training/test sets for algorithms, etc.) are fundamentally misaligned with the nature of the device described in the provided text.

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The Poly-Chem 90 glucose test system is an in vitro diagnostic procedure intended to measure qlucose quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypodycemia. and idiopathic glycemia, and of the pancreatic isle cell carcinoma.

The Poly-Chem 90 ALP test system is an in vitro diagnostic procedure intended to measure alkaline phosphatase quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Measurements of alkaline phosphatase are of use in the diagnosis, treatment, and investigation of hepatobiliary disease and in bone disease associated with increased osteoblastic activity. Alkaline phosphatase is also used in the diagnosis of parathyroid and intestinal disease.

The Poly-Chem 90 AST test system is an in vitro diagnostic procedure intended to measure aspartate aminotransferase (AST) quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. AST measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

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This document is an FDA 510(k) clearance letter for an in-vitro diagnostic device, specifically the Poly-Chem 90 Glucose, ALP, and AST tests. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way described in your request (e.g., performance metrics like accuracy, sensitivity, specificity, sample sizes used for testing, expert qualifications, or ground truth establishment for AI/ML devices).

The letter primarily focuses on:

• Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device's regulation number (21 CFR §862.1345), name (Glucose test system), regulatory class (Class II), and product codes (CFR, CJE, CIT).
• General Controls: Reminding the applicant of general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling).
• Indications for Use: Detailing what the Poly-Chem 90 Glucose, ALP, and AST tests are intended to measure and in what contexts these measurements are used for diagnosis and treatment.

Therefore, it is not possible to provide the requested information from the given text. This document is a regulatory approval notice, not a clinical study report or a technical performance evaluation. It confirms the device's marketability based on substantial equivalence, but it does not delve into the specific performance studies and acceptance criteria that led to that determination, especially not in the context of AI/ML performance evaluation as your questions imply.

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The Poly-Chem Creatinine test is intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a creatinine test system. It does not contain information about the acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. Therefore, I cannot fulfill your request based on the given input.

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NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

NycoCard U-Albumin Control consists of two control materials based on human urine and is intended to be used to confirm the efficacy of the NycoCard U-Albumin reagents and correct performance of the test.

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The provided text is an FDA 510(k) clearance letter for the NycoCard U-Albumin and NycoCard U-Albumin Control devices. It does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for a study proving device adherence to acceptance criteria.

The document primarily focuses on:

• Device Name: NycoCard U-Albumin and NycoCard U-Albumin Control
• Regulation Number and Name: 21 CFR § 866.5040, Albumin immunological test system
• Regulatory Class: Class II
• Product Code: DCF, JJX
• Indications For Use: To measure albumin in urine by immunochemical techniques, aiding in the diagnosis of kidney and intestinal diseases. The control material confirms the efficacy of reagents and correct test performance.
• FDA Clearance: States that the device is substantially equivalent to legally marketed predicate devices.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance or answer most of the requested study-specific questions.

The document states FDA's determination of "substantial equivalence" based on "indications for use stated in the enclosure." A full 510(k) submission would contain data demonstrating this equivalence, but that data is not included in the provided snippets.

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The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer.

The OC Auto Micro FOB Test is recommended for use in

• 1. Routine physical examinations
• 2. Monitoring for bleeding in patients
• 3. Screening for colorectal cancer or gastrointestinal bleeding

The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories.

This document is a 510(k) clearance letter for "The Polymedco OC Auto Micro 80 FOB Test." It describes the intended use of the device but does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the provided text. The document confirms the device's substantial equivalence to a predicate device and states its indications for use, but it does not detail the technical performance data that would typically be included in a study report.

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The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The OC Light test is recommended for use in 1) routine physical examinations 2) monitoring for bleeding in patients 3) screening for colorectal cancer or gastrointestinal bleeding

The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces.

The provided text is a 510(k) premarket notification approval letter for "The Polymedco OC Light FOB Test." This document approves the device based on substantial equivalence to a predicate device, but it does not contain the detailed study information, acceptance criteria, or performance data that would be found in a study report.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, because this information is not present in the provided text.

The text focuses on the regulatory approval and indications for use, without detailing the underlying performance studies.

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The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma.

The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.

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The provided text describes an FDA 510(k) premarket notification for the Polymedco Homocysteine Test. However, it does not contain specific details about acceptance criteria, device performance results, sample sizes, ground truth establishment, or study designs (e.g., MRMC, standalone).

Therefore, I cannot populate the table or answer the questions with the requested information based on the provided document. The document is primarily an FDA clearance letter and an "Indications for Use" statement, not a detailed study report.

Information NOT available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for establishing ground truth for the test set.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
• If a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

The document only states the device's intended use and FDA clearance, implying that studies were conducted to support the substantial equivalence claim, but the details of those studies are not included in this particular set of pages.

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